BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMEDICS

    MDR report key: 883059 · Received July 19, 2007

    Report

    Report Number
    9680548-2007-00005
    Event Type
    Other
    Date Received
    July 19, 2007
    Date of Event
    June 13, 2007
    Report Date
    July 4, 2007
    Manufacturer
    ROSSMAX INTERNATIONAL LTD.
    Product Code
    DXN
    PMA / PMN Number
    K013539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURNED UNIT FOR EVALUATION.

    Description of Event or Problem · 1

    ACCORDING TO HOMEDICS, INC. MDR NO. 1832894-2007-00067 STATING, "BP MONITOR READING HIGH. DOCTOR ADJUSTED HYPERTENSION MEDICATION BASED ON READINGS. SUBSEQUENTLY DOCTOR SUSPECTED THE READING WERE HIGH AND COMPARED BP MONITOR TO HIS OWN EQUIPMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEDICS BLOOD PRESSURE MONITOR DXN ROSSMAX INTERNATIONAL LTD. BPA-250WGN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR